title: Generic versus branded pharmacotherapy in Parkinson's disease: does it matter? A review.
abstract: There is an ongoing debate about generic drug use for a multitude of conditions including epilepsy, psychosis, hypertension, post-organ transplantation, and several infectious diseases. Most of the concerns involve drugs with narrow therapeutic indices. There is a heightened attention to health care costs and macroeconomic policy as well as microeconomic business decisions that may impact the use of generic drugs. The issues surrounding generic substitution for chronic degenerative conditions such as in Parkinson's disease (PD) continue to be controversial subjects for physicians, pharmacists, patients, Medicare/governmental insurance programs, and for private insurance companies. The United States Food and Drug Administration (FDA) requires that generic drugs meet a standard for bioequivalence prior to market approval, but this may not translate to therapeutic efficacy or to overall patient tolerance. In this review we will address issues related to the use of generics versus branded drugs in PD, and the potential impact substitution of generics may have on patients and on clinicians. Having proper documentation may help in deciding the appropriate usage of these drugs in PD. Medicare, governmental run health care systems, and third party insurance companies should in a complex disease such as PD, allow physicians and patients the chance to properly document the superiority of brand versus generic approaches. Currently, in the U.S, and in many countries around the world, there is no obligation for payers to respect these types of patient specific bedside trials, and there has been no standardization of the process.
authors.affiliation: Department of Neurology, University of Florida, McKnight Brain Institute, Movement Disorders Center, 100 S. Newell Drive, Gainesville, FL 32611, USA. crouix_scs@yahoo.com
authors.forename: Criscely L
authors.initials: CL
authors.lastname: Go
authors.forename: Raymond L
authors.initials: RL
authors.lastname: Rosales
authors.forename: Peter
authors.initials: P
authors.lastname: Schmidt
authors.forename: Kelly E
authors.initials: KE
authors.lastname: Lyons
authors.forename: Rajesh
authors.initials: R
authors.lastname: Pahwa
authors.forename: Michael S
authors.initials: MS
authors.lastname: Okun
mesh_terms: D000978:Antiparkinson Agents / Q000191:economics* / Q000627:therapeutic use*; D004347:Drug Interactions; D016568:Drugs, Generic / Q000627:therapeutic use*; D006801:Humans; D010300:Parkinson Disease / Q000188:drug therapy* / Q000191:economics* / Q000523:psychology; D010349:Patient Compliance; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics
chemical_list: D000978:Antiparkinson Agents; D016568:Drugs, Generic